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Lantheus Gets Complete Response Letter for Tumor Imaging Agent

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FDA issues Lantheus a Complete Response Letter for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emi...

Report: Three Finalists Emerge in Next Commissioner Search

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Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar wit...

FDA Declines to Approve Sobi Gout Therapy

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FDA issues Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricas...

EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing

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The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedl...

FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

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FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in com...

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...

FDA Cites Pinnacle Biologics for Misleading Photofrin Promo Videos

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FDA sends an untitled letter to Pinnacle Biologics, citing promotional videos for cancer therapy Photofrin (porfimer sodium).

Trodelvy OKd for First-Line Triple-Negative Breast Cancer

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FDA approves Gilead Sciences Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally ad...

Agency Says Firm Submitted Invalid Data

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FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the ag...

FDA Policymaking May Return to Normalcy: Former FDAers

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Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under ...